Trial Outcomes & Findings for Effect of Lumbar Bracing on Spinal Function (NCT NCT02251106)

Results Overview

The Oswestry Disability Index (ODI) questionnaire is a self-reported measure of function that examines the perceived level of disability. The ODI is made up of 10 questions. Each question is scored from 0-5 (minimum to maximum) The point total from each section is summed and then divided by the total number of questions answered and multiplied by 100 to create a percentage disability. The scores range from 0-100% with lower scores meaning less disability. If one section is missed (or not applicable) the score is calculated: (Total scored) / (total possible score with section removed) x 100 = \_\_%

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

2 weeks

Results posted on

2023-03-08

Participant Flow

Participant milestones

Participant milestones
Measure	-LBP/-Brace No brace. Subjects in this arm did not have back pain nor did they wear a brace (asymptomatic controls).	-LBP/+Brace Intervention = Lumbar corset (Quickdraw, Aspen Medical Products) Subjects in this arm did not have back pain but wore a brace for a two-week period (asymptomatic intervention). Subjects had their spine function measured before and after a two-week period.	+LBP/+Brace Intervention = Lumbar corset (Quickdraw, Aspen Medical Products) Subjects in this arm had back pain and wore a brace for a two-week period (symptomatic intervention). Subjects had their spine function measured before and after a two-week period.
Overall Study STARTED	19	18	17
Overall Study COMPLETED	19	18	17
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Lumbar Bracing on Spinal Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	-LBP/-Brace n=19 Participants No brace. Subjects in this arm did not have back pain nor did they wear a brace (asymptomatic controls).	-LBP/+Brace n=18 Participants Intervention = Lumbar corset (Quickdraw, Aspen Medical Products) Subjects in this arm did not have back pain but wore a brace for a two-week period (asymptomatic intervention). Subjects had their spine function measured before and after a two-week period.	+LBP/+Brace n=17 Participants Intervention = Lumbar corset (Quickdraw, Aspen Medical Products) Subjects in this arm had back pain and wore a brace for a two week period (symptomatic intervention). Subjects had their spine function measured before and after a two week period.	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	18 Participants n=7 Participants	17 Participants n=5 Participants	54 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	36.1 years STANDARD_DEVIATION 15.3 • n=5 Participants	33.1 years STANDARD_DEVIATION 12.9 • n=7 Participants	39.2 years STANDARD_DEVIATION 12.0 • n=5 Participants	36.1 years STANDARD_DEVIATION 13.5 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	26 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	28 Participants n=4 Participants
Region of Enrollment Canada	19 participants n=5 Participants	18 participants n=7 Participants	17 participants n=5 Participants	54 participants n=4 Participants
Oswestry Disability Index	.42 units on a scale STANDARD_DEVIATION .9 • n=5 Participants	.83 units on a scale STANDARD_DEVIATION 1.76 • n=7 Participants	10.41 units on a scale STANDARD_DEVIATION 5.87 • n=5 Participants	3.08 units on a scale STANDARD_DEVIATION 5.11 • n=4 Participants

PRIMARY outcome

Timeframe: 2 weeks

The Oswestry Disability Index (ODI) questionnaire is a self-reported measure of function that examines the perceived level of disability. The ODI is made up of 10 questions. Each question is scored from 0-5 (minimum to maximum) The point total from each section is summed and then divided by the total number of questions answered and multiplied by 100 to create a percentage disability. The scores range from 0-100% with lower scores meaning less disability. If one section is missed (or not applicable) the score is calculated: (Total scored) / (total possible score with section removed) x 100 = \_\_%

Outcome measures

Outcome measures
Measure	-LBP/-Brace n=19 Participants No brace. Subjects in this arm did not have back pain nor did they wear a brace (asymptomatic controls).	-LBP/+Brace n=18 Participants Intervention = Lumbar corset (Quickdraw, Aspen Medical Products) Subjects in this arm did not have back pain but wore a brace for a two week period (asymptomatic intervention). Subjects had their spine function measured before and after a two week period.	+LBP/+Brace n=17 Participants Intervention = Lumbar corset (Quickdraw, Aspen Medical Products) Subjects in this arm had back pain and wore a brace for a two-week period (symptomatic intervention). Subjects had their spine function measured before and after a two-week period.	-LBP/-Brace @ 2 Weeks n=19 Participants	-LBP/+Brace @ 2 Weeks n=18 Participants	+LBP/+Brace @ 2 Weeks n=17 Participants
Oswestry Disability Index	.42 score on a scale Standard Deviation .9	.83 score on a scale Standard Deviation 1.76	10.41 score on a scale Standard Deviation 5.87	.42 score on a scale Standard Deviation 1.02	.52 score on a scale Standard Deviation 1.31	6.1 score on a scale Standard Deviation 5.62

SECONDARY outcome

Timeframe: 2 weeks

This is a timed test of spine endurance where subjects are asked to straighten their backs from a semi-prone position. In patients who experience no difficulty in holding the position, the test is stopped after 240s. A position-holding time less than 176 seconds predicts low back pain during the next year in males, whereas a time greater than 198 seconds predicts absence of low back pain.

Outcome measures

Outcome measures
Measure	-LBP/-Brace n=19 Participants No brace. Subjects in this arm did not have back pain nor did they wear a brace (asymptomatic controls).	-LBP/+Brace n=18 Participants Intervention = Lumbar corset (Quickdraw, Aspen Medical Products) Subjects in this arm did not have back pain but wore a brace for a two week period (asymptomatic intervention). Subjects had their spine function measured before and after a two week period.	+LBP/+Brace n=17 Participants Intervention = Lumbar corset (Quickdraw, Aspen Medical Products) Subjects in this arm had back pain and wore a brace for a two-week period (symptomatic intervention). Subjects had their spine function measured before and after a two-week period.	-LBP/-Brace @ 2 Weeks n=19 Participants	-LBP/+Brace @ 2 Weeks n=18 Participants	+LBP/+Brace @ 2 Weeks n=17 Participants
Modified Sorensen Test	96.47 seconds Standard Deviation 62.61	119.83 seconds Standard Deviation 84.07	49.76 seconds Standard Deviation 23.67	119.21 seconds Standard Deviation 65.48	129.00 seconds Standard Deviation 88.14	54.35 seconds Standard Deviation 30.59

SECONDARY outcome

Timeframe: 2 weeks

Population: Outcome measure not assessed.

This test uses a blunt probe to non-invasively push into the back of a prone, resting subject.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: Outcome measure not assessed.

This test uses ultrasonic imaging to visualize spine muscles during simple tasks such as arm extension

Outcome measures

Outcome data not reported

Adverse Events

-LBP/-Brace

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

-LBP/+Brace

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

+LBP/+Brace

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Greg Kawchuk

University of Alberta

Phone: 780-492-6891

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place